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Operative Procedures Vs. Endovascular Neurosurgery for Untreated Pseudotumor Trial (OPEN-UP)
Pseudotumor cerebri, also called idiopathic intracranial hypertension (IIH), is characterized by elevated intracranial pressure, headache, and if severe, vision loss. IIH is difficult to treat. Medical management may not adequately resolve the symptoms, and surgical management (primarily through cerebrospinal fluid \[CSF\] shunting) has a high failure rate. Recently, a relationship between IIH and stenosis of the dural venous sinuses (the veins that drain blood from the brain) has been reported. In patients with IIH in whom there is stenosis of one or more dural venous sinuses, placing a stent in the venous sinus may improve patients' objective symptoms (such as visual loss and papilledema) and subjective symptoms (such as headache). This study will determine whether dural venous sinus stenting is as effective as CSF shunting (considered the standard surgical treatment) in treating IIH patients who have moderate vision loss and stenosis of the dural venous sinuses.
Details
| Lead sponsor | St. Joseph's Hospital and Medical Center, Phoenix |
|---|---|
| Phase | NA |
| Status | SUSPENDED |
| Enrolment | 80 |
| Start date | 2020-06-03 |
| Completion | 2025-12 |
Conditions
- Pseudotumor Cerebri
- Idiopathic Intracranial Hypertension (IIH)
Interventions
- Dural Venous Sinus Stenting
- Cerebrospinal Fluid Shunting
Primary outcomes
- Perimetric mean deviation (PMD) at six months — Six months
PMD was chosen as a primary outcome due to its generalizability, test-retest reliability and standardization across centers, as well as its sensitivity to severity and progression of visual symptoms of IIH. Based on previous work by the Neuro-Ophthalmology Research Disease Investigator Consortium (NORDIC) investigators, we defined the upper and lower bounds of visual field loss severity for study inclusion as between -8 and -30 dB in the worst-affected eye. The upper limit of -8 dB ensures enough baseline visual loss to consider surgical treatment and allow room for improvement, while the lower limit of -30 dB ensures that patients with severe visual loss unlikely to significantly improve with any treatment would be excluded. PMD will be tested using Swedish Interactive Threshold Algorithm (SITA) standard 24-2 perimetry with stimulus size III.
Countries
United States